Common use of Tech Transfer Clause in Contracts

Tech Transfer. 4.5.1 To facilitate the establishment of AbbVie’s second supply source of ribavirin tablets in twice daily and once daily dosage forms, within *** days of the Effective Date, the Parties shall enter into a tech transfer plan (the “Tech Transfer Plan”). The Tech Transfer Plan will include provisions requiring Company to make available to AbbVie copies of the physical embodiment of those processes, protocols, procedures, methods, tests and other information, relating specifically to the Manufacturing of Product. Company shall provide reasonable assistance in order to facilitate the establishment of a back-up supplier or the transfer of Manufacturing of the Product to AbbVie or such other Third Party that AbbVie designates. Notwithstanding the foregoing, the Parties acknowledge that Kadmon shall not be able to provide access to the DMF for the Company’s current API CMO. 4.5.2 At AbbVie’s request, and coordinated through the JPMT established under the License Agreement, Company shall cause appropriate employees and representatives of Company and its appropriate Affiliates to meet with the employees of AbbVie or its designee at appropriate locations, from time to time, as reasonably requested by AbbVie, to facilitate the transfer of Manufacturing process. Company shall also take all actions reasonably necessary to effectuate the royalty free transfer from Company or any of its CMOs (including Approved Subcontractors) to AbbVie or such Third Party supplier selected by AbbVie of Intellectual Property Rights owned or controlled by Company that are reasonably necessary and useful to Manufacture Product so as to enable AbbVie or such Third Party supplier to Manufacture Product. Company shall also cooperate with AbbVie CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION to promptly prepare and file all necessary regulatory submissions to accommodate such alternative supply arrangements. 4.5.3 In connection with the activities undertaken by Company under the Tech Transfer Plan, AbbVie shall reimburse Company’s (a) pre-approved travel expenses (undertaken in accordance with applicable AbbVie travel policies); (b) personnel expenses incurred on-site at AbbVie’s or its designee’s facility(ies) at a fully burdened rate equal to $200/hour; and (c) any actual, reasonable and documented costs and expenses required to be paid to Third Party CMOs. 4.5.4 To the extent agreed upon by the Parties in writing, the Parties will cooperate to identify and qualify an alternative supplier of API for the purposes of the Parties establishing a second source of API. If the Parties agree to cooperate then the Parties shall agree on the manner of sharing the costs of such identification and qualification.

Tech Transfer. 4.5.1 To facilitate the establishment of AbbVie’s second supply source of ribavirin tablets in twice daily and once daily dosage forms, within *** days of Promptly following the Effective Date, Pfenex and Hospira shall develop and reasonably agree through the Executive Steering Committee on a plan, which plan shall (a) be consistent in form and scope of those technology transfer plans used by Pfenex in connection with its transfer of the process related to both Drug Substance and Product to Third Parties prior to the Signature Date (access to which was provided to Hospira prior to the Signature Date) and (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties shall enter into a tech transfer plan on the Signature Date and referencing this Agreement (the “Tech Technical Transfer Plan”) of the activities to be conducted by each Party to facilitate Hospira’s or the Designated Product Manufacturer’s establishment of manufacturing capabilities for the Drug Substance and Product, including transfer of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Product, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Tech Technical Transfer Plan will shall also include provisions requiring Company a target completion date prior to make available to AbbVie copies the initiation of the physical embodiment Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of those processesan equal number of representatives of each of Pfenex and Hospira (up to a maximum number of three (3) representatives each), protocolswhich shall be responsible for overseeing the implementation of the Technical Transfer Plan. Each Party shall be responsible for all of its own costs and expenses incurred in connection with the performance of its obligations under the Technical Transfer Plan and Hospira shall be responsible for any payments owed to any Designated Product Manufacturer in connection with the Technical Transfer Plan. After completion of activities assigned to Pfenex under the Technical Transfer Plan, procedures, methods, tests Pfenex agrees to reasonably [***] Certain information in this document has been omitted and other information, relating specifically filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Manufacturing omitted portions. support Hospira’s or the Designated Product Manufacturer’s manufacture of Product. Company Drug Substance and Product hereunder, at Hospira’s reasonable request and Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel providing such support; provided, that Pfenex shall provide reasonable assistance in order to facilitate the establishment [***] of a back-up supplier or the transfer of Manufacturing of the Product to AbbVie or such other Third Party that AbbVie designatessupport without charge. Notwithstanding the foregoing, the Parties acknowledge that Kadmon shall not be able if Hospira requests Pfenex’s cooperation with respect to provide access to the DMF for the Company’s current API CMO. 4.5.2 At AbbVie’s request, and coordinated through the JPMT established under the License Agreement, Company shall cause appropriate employees and representatives of Company and its appropriate Affiliates to meet with the employees of AbbVie or its designee at appropriate locations, from time to time, as reasonably requested by AbbVie, to facilitate the transfer of Manufacturing process. Company manufacturing capabilities to a second Person or facility (e.g., to a Designated Product Manufacturer if the Technical Transfer Plan established manufacturing capabilities at Hospira or to a second Designated Product Manufacturer) Hospira shall also take all actions reasonably necessary to effectuate pay Pfenex at its Commercial Hourly Rate for the royalty free transfer from Company or any of time spent by its CMOs (including Approved Subcontractors) to AbbVie or such Third Party supplier selected by AbbVie of Intellectual Property Rights owned or controlled by Company that are reasonably necessary personnel and useful to Manufacture Product so as to enable AbbVie or such Third Party supplier to Manufacture Product. Company shall also cooperate with AbbVie CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTIONreimburse Pfenex for its out-of-pocket costs and expenses incurred, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***in each case, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION to promptly prepare and file all necessary regulatory submissions to accommodate such alternative supply arrangements. 4.5.3 In in connection with Pfenex cooperating at Hospira’s request. For clarity, (x) the activities undertaken by Company under Technical Transfer Plan shall not include the Tech Transfer Planscale-up of the manufacturing process to commercial scale, AbbVie validation of the manufacturing process or validation of the quality control, quality assessment or release methods or protocols for such purposes, all of which Hospira shall reimburse Company’s (a) pre-approved travel expenses (undertaken in accordance with applicable AbbVie travel policies); (b) personnel expenses incurred on-site at AbbVie’s or its designee’s facility(ies) at a fully burdened rate equal to $200/hourbe responsible for; and (cy) Pfenex shall not have any actual, reasonable and documented costs and expenses required obligation to be paid manufacture or supply to Third Party CMOsHospira any Drug Substance or Product. 4.5.4 To the extent agreed upon by the Parties in writing, the Parties will cooperate to identify and qualify an alternative supplier of API for the purposes of the Parties establishing a second source of API. If the Parties agree to cooperate then the Parties shall agree on the manner of sharing the costs of such identification and qualification.

Tech Transfer. 4.5.1 To facilitate (a) MERSANA shall have the establishment of AbbVie’s second supply source of ribavirin tablets in twice daily and once daily dosage formsright, within *** days of at any time after the Effective Date, to require SNFX to effect a transfer to MERSANA, or any Affiliate or CMO designated by MERSANA, of SNFX’s Know-How relating to the Parties shall enter into a tech transfer plan then-current process for the Manufacture of the Materials or the bioconjugation and Manufacture of remodeled antibodies using the Licensed Technology (collectively, the “Manufacturing Processes”) as is necessary and useful to enable MERSANA to implement the Manufacturing Processes at facilities designated by MERSANA (such transfer, the “Tech Transfer PlanTransfer”). The SNFX shall provide, and shall use Commercially Reasonable Efforts to cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), the reasonable assistance requested by MERSANA to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to implement the Manufacturing Processes at the facilities designated by MERSANA. If requested by ▇▇▇▇▇▇▇, such assistance shall include facilitating the entering into of agreements with applicable CMOs relating to the Manufacture of the Materials and the bioconjugation and Manufacture of the remodeled antibodies using the Licensed Technology. Without limitation to the foregoing, in connection with each Tech Transfer Plan will include provisions requiring Company Transfer: (1) SNFX shall make available, and shall use Commercially Reasonable Efforts to cause its CMOs to make available (including by using Commercially Reasonable Efforts to AbbVie copies of negotiate contractual obligations for such CMOs to do so under agreements entered into following the physical embodiment of those processesEffective Date), protocolsto MERSANA (or its Affiliates or designated CMOs, proceduresas applicable) from time to time as MERSANA may reasonably request, methods, tests and other information, all Manufacturing-related Know-How relating specifically to the Manufacturing of Product. Company shall provide reasonable assistance in order to facilitate the establishment of a back-up supplier or the transfer of Manufacturing of the Product to AbbVie or such other Third Party that AbbVie designates. Notwithstanding the foregoing, the Parties acknowledge that Kadmon shall not be able to provide access to the DMF for the Company’s current API CMO. 4.5.2 At AbbVie’s requestProcesses, and coordinated through all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the JPMT established under the License Agreement, Company Manufacturing Processes; (2) SNFX shall cause all appropriate employees and representatives of Company SNFX and its appropriate Affiliates to meet with the with, and shall use Commercially Reasonable Efforts to cause all appropriate employees of AbbVie or its designee at appropriate locations, from time to time, as reasonably requested by AbbVie, to facilitate the transfer of Manufacturing process. Company shall also take all actions reasonably necessary to effectuate the royalty free transfer from Company or any and representatives of its CMOs to meet with (including Approved Subcontractorsby using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), employees or representatives of MERSANA (or its Affiliates or designated CMOs, as applicable) at the applicable Manufacturing facility at mutually convenient times to assist with the working up and use of the Manufacturing Processes and with the training of MERSANA’s personnel (or its Affiliates’ or designated CMOs’ personnel, as applicable) to AbbVie or such Third Party supplier selected by AbbVie of Intellectual Property Rights owned or controlled by Company that are the extent reasonably necessary and or useful to Manufacture Product enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes; and (3) SNFX shall provide, and shall use Commercially Reasonable Efforts to cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), such other assistance as MERSANA (or its Affiliates or designated CMOs, as applicable) may reasonably request to enable AbbVie MERSANA (or such Third Party supplier its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes and otherwise to Manufacture Product. Company shall also cooperate with AbbVie CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION the Materials and to promptly prepare perform bioconjugation and file all necessary regulatory submissions to accommodate such alternative supply arrangementsManufacture the remodeled antibodies using the Licensed Technology. 4.5.3 In connection with the activities undertaken by Company under (b) MERSANA shall pay to CMOs all verifiable costs incurred directly as a result of performing the Tech Transfer Planand pay to SNFX all verifiable, AbbVie out-of-pocket costs and labor [**] incurred directly as a result of performing the Tech Transfer. MERSANA shall reimburse Company’s make such payment within [**] days following SNFX or a CMO providing MERSANA with an invoice and reasonable supporting documentation (aincluding receipts) pre-approved travel expenses (undertaken in accordance with applicable AbbVie travel policies); (b) personnel expenses incurred on-site at AbbVie’s or its designee’s facility(ies) at a fully burdened rate equal to $200/hour; and therefor. (c) Without limiting the foregoing, in the event that SNFX makes any actualmodification, reasonable improvement, alteration or enhancement relating to the Manufacture of the Materials or the bioconjugation or Manufacture of the remodeled antibodies using the Licensed Technology after completion of the activities set forth under this Section 2.7, SNFX shall promptly disclose such Improvement to MERSANA, and documented costs shall, at ▇▇▇▇▇▇▇’s request, perform technology transfer with respect to such Improvement in the same manner as provided in this Section 2.7. (d) Access to Tech Transfer assistance and expenses required consultation shall be requested and coordinated through a single contact person to be paid to Third Party CMOsdesignated by SNFX. 4.5.4 To the extent agreed upon by the Parties in writing, the Parties will cooperate to identify and qualify an alternative supplier of API for the purposes of the Parties establishing a second source of API. If the Parties agree to cooperate then the Parties shall agree on the manner of sharing the costs of such identification and qualification.

Tech Transfer. 4.5.1 To facilitate (a) MERSANA shall have the establishment of AbbVie’s second supply source of ribavirin tablets in twice daily and once daily dosage formsright, within *** days of at any time after the Effective Date, to require SNFX to effect a transfer to MERSANA, or any Affiliate or CMO designated by MERSANA, of SNFX’s Know-How relating to the Parties shall enter into a tech transfer plan then-current process for the Manufacture of the Materials and/or the bioconjugation and Manufacture of remodeled antibodies using the Licensed Technology (collectively, the “Manufacturing Processes”) as is necessary and useful to enable MERSANA to implement the Manufacturing Processes at facilities designated by MERSANA (such transfer, the “Tech Transfer PlanTransfer”). The SNFX shall provide, and shall use Commercially Reasonable Efforts to cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), the reasonable assistance requested by MERSANA to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to implement the Manufacturing Processes at the facilities designated by MERSANA. If requested by MERSANA, such assistance shall include facilitating the entering into of agreements with applicable CMOs relating to the Manufacture of the Materials and the bioconjugation and Manufacture of the remodeled antibodies using the Licensed Technology. Without limitation to the foregoing, in connection with each Tech Transfer Plan will include provisions requiring Company Transfer: (1) SNFX shall make available, and shall use Commercially Reasonable Efforts to cause its CMOs to make available (including by using Commercially Reasonable Efforts to AbbVie copies of negotiate contractual obligations for such CMOs to do so under agreements entered into following the physical embodiment of those processesEffective Date), protocolsto MERSANA (or its Affiliates or designated CMOs, proceduresas applicable) from time to time as MERSANA may reasonably request, methods, tests and other information, all Manufacturing-related Know-How relating specifically to the Manufacturing of Product. Company shall provide reasonable assistance in order to facilitate the establishment of a back-up supplier or the transfer of Manufacturing of the Product to AbbVie or such other Third Party that AbbVie designates. Notwithstanding the foregoing, the Parties acknowledge that Kadmon shall not be able to provide access to the DMF for the Company’s current API CMO. 4.5.2 At AbbVie’s requestProcesses, and coordinated through all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the JPMT established under the License Agreement, Company Manufacturing Processes; (2) SNFX shall cause all appropriate employees and representatives of Company SNFX and its appropriate Affiliates to meet with the with, and shall use Commercially Reasonable Efforts to cause all appropriate employees of AbbVie or its designee at appropriate locations, from time to time, as reasonably requested by AbbVie, to facilitate the transfer of Manufacturing process. Company shall also take all actions reasonably necessary to effectuate the royalty free transfer from Company or any and representatives of its CMOs to meet with (including Approved Subcontractorsby using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), employees or representatives of MERSANA (or its Affiliates or designated CMOs, as applicable) at the applicable Manufacturing facility at mutually convenient times to assist with the working up and use of the Manufacturing Processes and with the training of MERSANA’s personnel (or its Affiliates’ or designated CMOs’ personnel, as applicable) to AbbVie or such Third Party supplier selected by AbbVie of Intellectual Property Rights owned or controlled by Company that are the extent reasonably necessary and or useful to Manufacture Product enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes; and (3) SNFX shall provide, and shall use Commercially Reasonable Efforts to cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), such other assistance as MERSANA (or its Affiliates or designated CMOs, as applicable) may reasonably request to enable AbbVie MERSANA (or such Third Party supplier its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes and otherwise to Manufacture Product. Company the Materials and to perform bioconjugation and Manufacture the remodeled antibodies using the Licensed Technology. (b) MERSANA shall also cooperate with AbbVie CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTIONpay to CMOs all verifiable costs incurred directly as a result of performing the Tech Transfer and pay to SNFX all verifiable, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK out-of-pocket costs and labor [***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION to promptly prepare ] incurred directly as a result of performing the Tech Transfer. MERSANA shall make such payment within [***] days following SNFX or a CMO providing MERSANA with an invoice and file all necessary regulatory submissions to accommodate such alternative supply arrangementsreasonable supporting documentation (including receipts) therefor. 4.5.3 In connection with the activities undertaken by Company under the Tech Transfer Plan, AbbVie shall reimburse Company’s (a) pre-approved travel expenses (undertaken in accordance with applicable AbbVie travel policies); (b) personnel expenses incurred on-site at AbbVie’s or its designee’s facility(ies) at a fully burdened rate equal to $200/hour; and (c) Without limiting the foregoing, in the event that SNFX makes any actualmodification, reasonable improvement, alteration or enhancement relating to the Manufacture of the Materials or the bioconjugation or Manufacture of the remodeled antibodies using the Licensed Technology after completion of the activities set forth under this Section 2.6, SNFX shall promptly disclose such Improvement to MERSANA, and documented costs shall, at MERSANA’s request, perform technology transfer with respect to such Improvement in the same manner as provided in this Section 2.6. (d) Access to Tech Transfer assistance and expenses required consultation shall be requested and coordinated through a single contact person to be paid to Third Party CMOsdesignated by SNFX. 4.5.4 To the extent agreed upon by the Parties in writing, the Parties will cooperate to identify and qualify an alternative supplier of API for the purposes of the Parties establishing a second source of API. If the Parties agree to cooperate then the Parties shall agree on the manner of sharing the costs of such identification and qualification.